Fulphila: Withdrawal of the marketing authorisation application

pegfilgrastim

Overview

On 3 August 2017, Mylan S.A.S. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fulphila, for reducing neutropenia in patients taking cancer treatments.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Fulphila (pegfilgrastim) (PDF/68.45 KB)


    First published: 15/09/2017
    Last updated: 29/05/2018
    EMA/577551/2017

  • Key facts

    Name
    Fulphila
    Product number
    EMEA/H/C/004262
    International non-proprietary name (INN) or common name
    • pegfilgrastim
    Active substance
    • pegfilgrastim
    Date of withdrawal
    03/08/2017
    Company making the application
    Mylan S.A.S
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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